D 02 - Processes for your operational management system - Set of documents
Document set - 108 process sheets for your operational management system
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See the set of documents D 15v15 ISO 9001 Readiness See the set of documents D 35v15 ISO 9001 Internal audit See the set of documents D 65v15 ISO 9001 package |
You have an unlimited access for one year to the whole set of documents. This includes access to all the modifications (improvements) which could be made during that period.
Description
All these documents can be modified to adapt to your needs and your context.
See also document set D 48 Quality manager function
See also document set D 52 QSE manager function
Documents present in the packages:
- D 65v15 package ISO 9001 version 2015 quality
- D 66v16 package IATF 16949 version 2016 automobile
- D 67v15 package ISO 14001 version 2015 environment
- D 68v18 package ISO 45001 version 2018 occupational health and safety
- D 69v18 package IMS QSE version 2018 integrated QSE management system
- D 70v18 package ISO 22000 version 2018 food safety
- D 71v16 package AS9100 version 2016 aerospace
- D 72v16 package ISO 13485 version 2016 medical devices
- D 73v07 package ISO 22716 version 2007 cosmetics
- D 74v22 package ISO 27001 version 2022 information security
- D 75v16 package ISO 37001 version 2016 anti-bribery
D 02 Process sheets for your management system | ||||
Codification | Title | Sub-clause | Pages | |
Management | ||||
PQBD02M1 | Develop strategy (example in pdf) | 5.1.1 | 2 | |
PQBD02M2 | Satisfy requirements | 4.2 | 2 | |
PQBD02M3 | Identify hazards and assess OH&S risks | ***6.1.1 | 2 | |
PQBD02M4 | Establish process ownership | 4.4 | 2 | |
PQBD02M5 | Establish policy | 5.2 | 2 | |
PQBD02M6 | Address risks | 6.1 | 2 | |
PQBD02M7 | Identify environmental aspects and impacts | *6.1.2 | 2 | |
PQBD02M8 | Implement preventive actions | **6.1.2.2 | 2 | |
PQBD02M9 | Plan the QMS (quality management system) | 6.2 | 2 | |
PQBD02M10 | Deploy objectives | *6.2.1 | 2 | |
PQBD02M11 | Acquire resources | 7.1 | 2 | |
PQBD02M12 | Communicate | 7.4; **8.5.5.1 | 2 | |
PQBD02M13 | Negotiate the contract | 8.2.1 | 2 | |
PQBD02M14 | Conduct second-party audit | **8.4.2.4.1 | 2 | |
PQBD02M15 | Measure the satisfaction | 9.1.2 | 2 | |
PQBD02M16 | Analyse data | 9.1.3 | 2 | |
PQBD02M17 | Audit | 9.2 | 2 | |
PQBD02M18 | Carry out management review | 9.3 | 2 | |
PQBD02M19 | Improve | 10.3; **10.3.1 | 2 | |
PQBD02M20 | Consult workers | ***5.4 | 2 | |
PQBD02M21 | Evaluate compliance | ***9.1.2 | 2 | |
PQBD02M22 | Assess risks | ¤¤¤6.1.2 | 2 | |
PQBD02M23 | Treat risks | ¤¤¤6.1.3 | 2 | |
PQBD02M24 | Delegate decision-making | ¤¤¤¤5.3 | 2 | |
Realization | ||||
PQBD02R1 | Guarantee product safety (example in pdf) | **4.4.1.2; ****8.1.3 | 2 | |
PQBD02R2 | Investigate incident | ***10.2 | 2 | |
PQBD02R3 | Elaborate contingency plans | **6.1.2.3 | 2 | |
PQBD02R4 | Maintain equipment | 7.1 | 2 | |
PQBD02R5 | Recall equipment | ****7.1.5.2 | 2 | |
PQBD02R6 | Manage calibration/verification records | **7.1.5.2.1 | 2 | |
PQBD02R7 | Carry out FMEA | 8.3; **7.3.1.1 | 2 | |
PQBD02R8 | Sterilize medical devices | ¤¤7.5 | 2 | |
PQBD02R9 | Carry out process review | 8.1 | 2 | |
PQBD02R10 | Manage waste | *8.1 | 2 | |
PQBD02R11 | Transfer of work | ****8.1 | 2 | |
PQBD02R12 | Manage critical items | ****8.1 f | 2 | |
PQBD02R13 | Manage operational risk | ****8.1.1 | 2 | |
PQBD02R14 | Struggle against counterfeit parts | ****8.1.4 | 2 | |
PQBD02R15 | Prevent emergency situations | *8.2 | 2 | |
PQBD02R16 | Implement PRPs | ¤8.2 | 2 | |
PQBD02R17 | Notify regulatory authorities | ¤¤8.2 | 2 | |
PQBD02R18 | Design and development | 8.3 | 2 | |
PQBD02R19 | Notify customers on changes | ****8.3.6 | 2 | |
PQBD02R20 | Assess embedded software | **8.3.2.3 | 2 | |
PQBD02R21 | Manage special characteristics | **8.3.3.3 | 2 | |
PQBD02R22 | Approve product | **8.3.4.4 | 2 | |
PQBD02R23 | Purchase components | 8.4 | 2 | |
PQBD02R24 | Control outsourced processes | 8.4 | 2 | |
PQBD02R25 | Manage external providers | ****8.4.1.1 | 2 | |
PQBD02R26 | Evaluate test reports | ****8.4.2 | 2 | |
PQBD02R27 | Meet statutory and regulatory requirements | **8.4.2.2 | 2 | |
PQBD02R28 | Produce | 8.5 | 2 | |
PQBD02R29 | Establish the HACCP plan | ¤8.5 | 2 | |
PQBD02R30 | Receive, store and deliver | 8.5.1 | 2 | |
PQBD02R31 | Implement control plan | **8.5.1.1 | 2 | |
PQBD02R32 | Inspect first article | ****8.5.1.3 | 2 | |
PQBD02R33 | Implement traceability | 8.5.2; **8.5.2.1 | 2 | |
PQBD02R34 | Manage changes | 8.5.6; **8.5.6.1 | 2 | |
PQBD02R35 | Use alternate methods | ****8.5.6.1.1 | 2 | |
PQBD02R36 | Sell products | 8.6 | 2 | |
PQBD02R37 | Approve rework and repair | **8.7.1.4; **8.7.1.5 | 2 | |
PQBD02R38 | Dispose of nonconforming products | **8.7.1.7 | 2 | |
PQBD02R39 | Inspect production | 9.1 | 2 | |
PQBD02R40 | Control nonconformities | 10.2 | 2 | |
PQBD02R41 | Implement corrective actions | 10.2 | 2 | |
PQBD02R42 | Solve problems | **10.2.3 | 2 | |
PQBD02R43 | Use error-proofing devices | **10.2.4 | 2 | |
PQBD02R44 | Meet security requirements | ¤¤¤8.1 | 2 | |
PQBD02R45 | Register and unsubscribe | ¤¤¤8.1 | 2 | |
PQBD02R46 | Distribute access | ¤¤¤8.1 | 2 | |
PQBD02R47 | Manage authentication | ¤¤¤8.1 | 2 | |
PQBD02R48 | Develop and support security | ¤¤¤8.1 | 2 | |
PQBD02R49 | Manage security continuity | ¤¤¤8.1 | 2 | |
PQBD02R50 | Implement security | ¤¤¤8.1 | 2 | |
PQBD02R51 | Manage networks | ¤¤¤8.1 | 2 | |
PQBD02R52 | Monitor after marketing | ¤¤8.2 | 2 | |
PQBD02R53 | Evaluate benefit/risk ratio | ¤¤8.2 | 2 | |
PQBD02R54 | Manage operational requirements | ¤¤¤¤8.1 | 2 | |
PQBD02R55 | Manage assets | ¤¤¤A.5.9 | 2 | |
PQBD02R56 | Manage identities | ¤¤¤A.5.16 | 2 | |
PQBD02R57 | Manage supplier security | ¤¤¤A.5.19 | 2 | |
PQBD02R58 | Manage ICT supply chain | ¤¤¤A.5.21 | 2 | |
PQBD02R59 | Manage cloud services | ¤¤¤A.5.23 | 2 | |
PQBD02R60 | Manage incidents | ¤¤¤A.5.24 | 2 | |
PQBD02R61 | Manage technical vulnerabilities | ¤¤¤A.8.8 | 2 | |
PQBD02R62 | Manage configuration | ¤¤¤A.8.9 | 2 | |
PQBD02R63 | Delete information | ¤¤¤A.8.10 | 2 | |
PQBD02R64 | Use cryptography | ¤¤¤A.8.24 | 2 | |
PQBD02R65 | Review information security | ¤¤¤A.5.35 | 2 | |
PQBD02R66 | Test | ¤¤¤A.8.29 | 2 | |
PQBD02R67 | Analyze business impact | ¤¤¤¤¤8.2.2 | 2 | |
PQBD02R68 | Recover activities | ¤¤¤¤¤8.4.5 | 2 | |
PQBD02R69 | Release of products and services | 8.6 | 2 | |
Support | ||||
PQBD02S1 | Maintain regulatory watch (example in pdf) | *6.1.3 | 2 | |
PQBD02S2 | Manage staff | 7.1.2 | 2 | |
PQBD02S3 | Acquire and maintain infrastructure | 7.1.3 | 2 | |
PQBD02S4 | Manage inspection means | 7.1.5 | 2 | |
PQBD02S5 | Manage laboratory | **7.1.5.3 | 2 | |
PQBD02S6 | Provide training | 7.2 | 2 | |
PQBD02S7 | Verify auditor competency | **7.2.3; **7.2.4 | 2 | |
PQBD02S8 | Empower employees | **7.3.2 | 2 | |
PQBD02S9 | Provide information | 7.5 | 2 | |
PQBD02S10 | Control documentation | 7.5.3 | 2 | |
PQBD02S11 | Keep accountability | 7.5.3 | 2 | |
PQBD02S12 | Manage configuration | ****8.1.2 | 2 | |
PQBD02S13 | Manage IT | 7.1.3 | 2 | |
PQBD02S14 | Apply discipline | ¤¤¤A.6.4 | 2 | |
PQBD02S15 | Manage the employment contract | ¤¤¤A.6.1 | 2 | |
PQBD02A01 | Processes and ISO 9001 sub-clauses | 1 | ||
PQBD02A02 | Process map | 4.4 | 1 | |
PQBD02A03 | Processes and sub-clauses other standards | 2 | ||
PQBD02List | List of processes | 3 | ||
Total | 226 |
* ISO 14001; ** IATF 16949; *** ISO 45001; ****AS9100D; ¤ISO 22000; ¤¤ISO 13485; ¤¤¤ISO 27001; ¤¤¤¤ISO 37001; ¤¤¤¤¤ISO22301
M: management process
R: realization process
S: support process